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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 04/20/2009
Event Type  Injury  
Event Description

It was reported initially that the vns patient was seen by a surgeon to possibly have the vns device removed, due to an unknown reason. Further follow up with the surgeon's office revealed that surgery is not planned, and they had referred the patient back to the neurologist to possibly have the device disabled. Despite good faith attempts made at the time to obtain additional information regarding the reason the device was to be disabled, no additional information had been received. It was later reported that the patient was scheduled for surgery to have the device removed as the patient was experiencing severe neck and chest pain where the vns device was located. Further follow up with the neurologist's office revealed that the pain was constant and there were no causal or contributory programmed setting changes, trauma, or manipulation reported to have occurred prior to the onset of the pain. It was noted that the patient had complained for months of excessive pain. Surgery occurred where it is known that the generator was explanted, which has been returned to manufacturer and analysis is underway. Despite good faith attempts with the surgeon to obtain whether the lead was explanted, no additional information has been received. There are no specific diagnostic test results available; however, the neurologist noted that the device was working properly.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1445400
Report Number1644487-2009-01732
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/22/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2008
Device MODEL Number102
Device LOT Number015644
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/13/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/22/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/20/2009 Patient Sequence Number: 1
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